CONCEPT: Crossover Efficacy Pain Trial in Motor Cortex Stimulation for Intractable Neuropathic Pain - Full Text View

Sponsored by:	Medtronic
Information provided by:	Medtronic
ClinicalTrials.gov Identifier:	NCT00122915

Purpose

The CONCEPT study has been designed to evaluate the safety and the efficacy of Motor Cortex Stimulation (MCS) with a new cortical lead (circular lead, eight electrodes, Medtronic Inc, Minneapolis, USA) in the treatment of intractable neuropathic pain, in particular for central post-stroke pain (CPSP) and trigeminal neuropathic pain (TGN)/facial pain.

Condition	Intervention	Phase
Pain, Intractable Facial Pain	Device: Cortical lead, 8 electrodes (Model 2976) with Synergy neurostimulator	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomized, Double Blind, Crossover, Multi-Center Study to Evaluate the Safety and the Efficacy of Motor Cortex Stimulation With the Cortical Stimulation Lead Model 2976 in Patients With Neuropathic Pain

Further study details as provided by Medtronic:

Primary Outcome Measures:

Adverse events reports
Pain assessed by Visual Analogue Scale (VAS)

Secondary Outcome Measures:

Quality of life
Disability
Analgesic, sedative or psychoactive medication intake

Estimated Enrollment:	104
Study Start Date:	June 2005
Estimated Study Completion Date:	December 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

CPSP or TGN/facial pain refractory to other medical treatments
Pain > 1 year prior to baseline
Pain intensity with an average daily VAS score > 5 demonstrated by 12 ratings across 4 days
Stable pain medication for > 1 month prior to baseline

Exclusion Criteria:

CPSP with important paresis/severe motor deficit in the area of pain
TGN/facial pain with complete deafferentation pain
Atypical facial pain, i.e. when objective evidence for neuropathic facial pain syndromes is lacking and when specific psychological and behavioral factors can be identified
Pain associated with malignant neoplastic disease anywhere in the body or head
History of epilepsy
Presence of a deterioration of cognitive functions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122915

Locations

Austria
Universitätsklinik Innsbruck, Universitätsklinik für Neurochirurgie
Innsbruck, Austria, 6020
Belgium
UZ Gasthuisberg , Department of Neurosurgery
Leuven, Belgium, 3000
AZ St Lucas, Neurochirugie
Gent, Belgium, 9000
Hopital Erasme, Service de Neurochirurgie
Brussels, Belgium, 1070
UCL St luc, Neurochirurgie
Brussels, Belgium, 1200
CH de la Citadelle
Liège, Belgium, 4000
Maria Middelares ZH
St. Niklaas, Belgium, 9100
Germany
Klinikum der Philipps-Universität Marburg
Marburg, Germany, 35043
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Germany, 23538
Spain
Santa Creu I Sant Pau, Servicio de Neurocirugia
Barcelona, Spain, 08025
Hospital Gregorio Maranon, Servicio de Neurologia
Madrid, Spain, 28007

Sponsors and Collaborators

Medtronic

Investigators

Principal Investigator:

Bart Nuttin, PhD, MD

UZ Gasthuisberg

More Information

Study ID Numbers:	CONCEPT
Study First Received:	July 21, 2005
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00122915
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by Medtronic:

Motor Cortex Stimulation
Pain treatment
Central post-stroke pain (CPSP)
Trigeminal neuropathic pain (TGN)

Facial pain
Neurostimuation
Cortical lead
Neuropathic pain

Study placed in the following topic categories:

Pain, Intractable
Signs and Symptoms
Facies
Cerebral Infarction

Facial Pain
Stroke
Neurologic Manifestations
Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009